Australia is planning to implement plain packaging for all brands of cigarettes during 2012, and recently introduced a bill to its parliament. However, an Editorial in TheLancet Oncology says that while many countries of varying income are supporting Australia’s trailblazing stance, a substantial number of developing countries are aligning themselves with the tobacco industry.

Member states of the World Trade Organization (WTO) gathered in June for a meeting of the organization’s Trade Related Aspects of Intellectual Property Rights (TRIPS) council. New Zealand, Norway, and Uruguay have expressed support for plain packaging, as have India, who agree plain packaging is antismoking. But the Dominican Republic, with support or sympathy from Honduras, Nicaragua, Ukraine, the Philippines, Zambia, Mexico, Cuba, and Ecuador, said it had “serious and grave concerns” about the bill, saying it violated international trademark law, and would drive down costs leading to increased counterfeiting.

However, legal advisors who support the legislation have told The Lancet Oncologythat they are confident the draft law fully complies with WTO obligations, and that they hope the case would provide an endorsement under international law of the importance of the WHO Framework Convention on Tobacco Control.

The Editorial says that the tobacco industry is important to many of these countries in terms of tax revenue and jobs, hence their alignment with big tobacco. However, these countries must also consider the health impact of the tobacco epidemic. Tobacco companies also continue to campaign against the legislation within Australia, running television advertisements and labelling the nation as a nanny state. But the country’s Federal Health Minister Nicola Roxon remains resolute, backed by experts who say plain packets can break the affiliation smokers have with a particular brand thereby helping them to quit, and also prevent teenagers from becoming smokers.

Despite Australia’s tobacco market being worth only AUS$10 billion—small on a global scale—big tobacco is trying to stop this law as it will set a precedent withCanada, the UK, and New Zealand, all expected to follow Australia’s lead. The US FDA is also looking at its cigarette packaging . The Editorial concludes: “It is unsurprising, therefore, that the tobacco industry should use its influence over other players to delay, frustrate, and block this important initiative. The sovereignty of countries should be absolute and not be influenced by multinational companies with complex accountability. This laudable move towards plain packaging must not be derailed by veiled tactics from companies with vested interests. Only then can progress be made to tackle tobacco-associated diseases, which are largely preventable, but mostly lethal.”

Researchers have warned of the health risks of electronic cigarettes, increasingly popular among smokers who want to quit the habit or at least smoke less. E-cigarettes look like the real thing but consist of a rechargeable battery, a cartridge and a mouthpiece. The e-cigarettes are said to have no tobacco, offering an alternative to the nicotine patch or gum. — ST PHOTO: CAROLINE CHIA

RESEARCHERS have warned of the health risks of electronic cigarettes, increasingly popular among smokers who want to quit the habit or at least smoke less. E-cigarettes look like the real thing but consist of a rechargeable battery, a cartridge and a mouthpiece. The e-cigarettes are said to have no tobacco, offering an alternative to the nicotine patch or gum.

With the US Food and Drug Administration deciding that e-cigarettes will be labelled as tobacco products and not as drug-delivery devices, manufacturers will be able to sell the products straight to consumers, according to a report published in the latest issue of the New England Journal of Medicine.

It was written by Nathan K Cobb, a pulmonologist and assistant professor at Georgetown University Medical Center and David B Abrams, an executive director of the Schroeder Institute.

They also said that prominent cigarette manufactures such as Philip Morris International and British American Tobacco are likely to come out with even more sophisticated nicotine inhalers in the future.

They also noted that the cartridge can be replaced by the user giving he or she control over the amount of nicotine put in.

Supporters of the e-cigarette argue that the products help people avoid smoking regular cigarettes. But scientists and consumer groups have raised concerns about their potential harm to health. The electronic butts produce a propylene glycol mist and include other chemicals which have not been tested properly. — KOREAN HERALD/ANN

On April 25, 2011, the Food and Drug Administration (FDA) announced its intention of regulating “electronic cigarettes” as tobacco products, having failed in its initial attempt to regulate them as drug-delivery devices. Previously, products delivering refined nicotine had either been regulated as pharmaceuticals (and subjected to the “safe and effective” standard used in drug approvals) or swiftly removed from the market to protect public safety. The FDA’s decision came after the courts blocked the agency from regulating these products as drug-delivery devices, holding that under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), products containing nicotine derived from . . .

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

In a “Perspective” published in the New England Journal of Medicine, researchers from the Legacy’s Steven A. Schroeder National Institute for Tobacco Research and Policy Studies explore the current regulatory climate around electronic cigarettes (“e-cigarettes”) and their safety. The authors, Nathan K. Cobb, MD, a pulmonologist and assistant professor at Georgetown University Medical Center, and David B. Abrams, PhD, executive director of the Schroeder Institute, also question future implications for physicians, policy makers and e-cigarette users.

E-cigarettes are constructed to mimic real cigarettes in size and appearance, but contain no tobacco and are not cigarettes at all. In reality they are delivery devices for refined nicotine, having more in common with inhalers used to treat asthma or other delivery devices for both approved and illicit drugs. Though individual brands vary in construction, the products generally produce a propylene glycol mist containing nicotine along with flavorings and other chemicals.

Currently, three interrelated products are being sold: the delivery device itself; cartridges that can contain up to 20 mg of nicotine; and refill kits that allow consumers to fill used cartridges with replacement nicotine solution. Some refill bottles, easily obtained over the Internet, contain enough nicotine to kill an adult if accidentally ingested.

The U.S. Food and Drug Administration (FDA) announced April 25, 2011, that it would regulate e-cigarettes as “tobacco products” and not as “drug-delivery devices.” That action came after federal courts blocked the agency from regulating the products as drug-delivery devices. The courts maintained that, under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), the FDA must regulate as tobacco products any product that contains nicotine from tobacco and that makes no claims to be therapeutic. These decisions together, the authors note, “upend[ed] the status quo” by having the effect of allowing the sale of unregulated refined nicotine directly to consumers, unless and until the FDA takes further action.

“The court’s decision that e-cigarettes should be regulated as tobacco products and not as drug-delivery devices has substantially delayed the FDA regulatory process that normally protects the public health. It has the practical effect of allowing manufacturers to sell potentially dangerous refined nicotine products directly to consumers,” said Cobb. “It is entirely possible that future modifications to the products will improve the efficiency of nicotine delivery and could dramatically increase the risks of addiction, abuse and serious overdose.”

While most devices and nicotine fluids are produced by small manufacturers, Cobb and Abrams note that the fact that leading cigarette manufacturers Philip Morris International and British American Tobacco recently purchased sophisticated nicotine inhaler technologies may be an indication that both companies are developing next generation nicotine delivery devices of their own.

Abrams, a professor at Johns Hopkins Bloomberg School of Public Health added “Any refined nicotine product, whether used for smoking cessation and tested and approved by the FDA (like the Nicotrol inhaler) or a new product designed for ‘reduced or modified’ risk, can and must be tested and strictly regulated before being introduced to the market.”

The authors argue that a comprehensive approach to regulating products containing refined nicotine is needed to protect the public’s health and should involve Congress, the courts and the FDA.

The devices do not reliably deliver nicotine, and have not been sufficiently evaluated in scientific studies the way the FDA requires of other drugs and devices used for smoking cessation. Smokers attempting to use e-cigarettes as quitting aids will most likely find them ineffective due to the fluctuating nicotine content and unpredictable delivery.

Manufacturers sell cartridges with a range of up to 20 milligrams of nicotine. However, refill kits allow consumers to fill used cartridges with replacement solutions at much higher doses. In fact, the devices are not limited to delivering nicotine. The paper notes that instructions for filling cartridges with marijuana hash oil can be easily accessed on the Internet.

The safety of inhaling propylene glycol over an extended period of time has not been studied in humans.

E-cigarettes may serve as a “bridge product” that smokers use in places where traditional tobacco smoking is prohibited, thus perpetuating their addiction and use of real cigarettes. Additionally, they may be used as a ‘starter’ product for young people considering smoking, especially since the cartridges can be purchased over the Internet with tempting flavoring like grape and chocolate.

In their conclusion, Cobb and Abrams counter the argument made by e-cigarette advocates that taking the devices off the market could mean current users would be forced to return to traditional tobacco products. Instead, the two researchers point to the multiple pharmaceutical-grade nicotine products on the market that have been regulated, approved and deemed safe and effective by the FDA, including patches, gums, lozenges, nasal sprays and even an FDA-approved inhaler. The two researchers also state that current users should pursue research-proven effective cessation tools, such as nicotine replacement products, telephone quit lines, and Web-based cessation services, as well as non-nicotine pharmacotherapies like bupropion and varenicline.

The average price of tobacco in Malawi, the world’s largest producer of the burley variety, is selling for 39 percent less than the government’s recommended price, the Daily Times reported.

The leaf is selling for an average $1.10 per kilogram (2.2 pounds) since the auction season started on March 14, the Blantyre-based newspaper said, citing Bruce Munthali, the chief executive officer of the Tobacco Control Commission. The country has generated $104.8 million from tobacco sales this year, it said.

By REUTERS

The Supreme Court ruled Friday that the federal government was not liable for damages from health-related lawsuits against tobacco companies, possibly amounting to many billions of dollars. The decision was a major defeat for the tobacco industry, which faces suits from several provinces seeking to recoup health care costs.The industry had argued that the government had allowed and regulated the use of tobacco and should therefore take some of the responsibility. The court disagreed, 9-0. The decision came in a suit by the province of British Columbia against R. J. Reynolds Tobacco, Japan Tobacco’s JTI-Macdonald unit, Rothmans Benson & Hedges and Imperial Tobacco Canada.

Executive Summary• The public consultation generated over 85 000 contributions, which illustrates a greatinterest in EU tobacco control policy. Citizen contributions accounted for 96% of thesurvey response. Almost 2/3 of the contributions were from just two Member States: Italyand Poland.• It is difficult to draw firm conclusions from the outcome of the public consultationprocedure. In general, opinions varied significantly between and also within categories ofrespondents. Arguments provided by respondents in the ‘free text’ sections of theconsultation present a variety of different justifications for policy action.• Those who were in favour of extending the scope of the Directive to all tobacco andnicotine products argued that these products present hazards to public health. Somerespondents suggested nicotine products should be regulated under pharmaceuticallegislation. Others arguing against the extension of the scope raised concerns about thelack of scientific evidence and claimed that the use of many novel forms of tobacco andnicotine products are healthier than cigarette use.• Respondents in favour of keeping the ban on oral tobacco (snus) or banning all smokelesstobacco argued that, although some of these products are considered ‘reduced risk’ tobaccoproducts, oral tobacco is harmful to health. . Those who were in favour of lifting thecurrent ban on oral tobacco, referred to snus as a healthier alternative to tobacco smokingand a potentially effective way to quit smoking.• Respondents in favour of mandatory pictorial warnings and plain or generic tobaccopackaging stressed that these measures would eliminate the advertising and marketingeffects utilized by the industry and will provide equal protection of European citizens.According to the opponents of these measures, implementing mandatory pictorialwarnings and generic packaging would have little to no impact on the uptake of smoking,especially among youth. Opponents also expressed legal concerns about intellectualproperty and suggested that generic and plain packaging could increase illicit trade intobacco.• Most of the respondents were in favour of a common compulsory reporting format,underlining that it would facilitate the comparison and analysis of ingredients information.• Respondents in favour of regulating ingredients said that restricting certain additivesalongside sweet, fruity, floral, and candy flavours could prevent young people from takingup smoking. Additionally, these actions would have the added benefit of facilitating intra-EU trade by synthesizing current ingredients regulation in Member States. Opponents, onthe contrary, said that ingredients and additives do little to influence youth uptake and thata regulation of ingredients could discriminate against certain varieties and brands oftobacco.• Respondents in favour of banning the sale of tobacco products over the internet and fromvending machines indicated that these actions would reduce the advertisement of tobaccoproducts through these channels and better restrict young people’s access to tobaccoproducts. It was also argued that a tobacco display ban at the point of sale would limityouth smoking and deter tobacco purchasing by adults. Opponents raised concerns about alack of scientific evidence, market difficulties for new, unadvertised products andexcessive intervention in consumers’ right to product choice.

http://infojustice.org/archives/4405

Australian Ambassador Kim Beasley has vowed that Australia will not change the Tobacco Plain Packaging Act, which prohibits cigarette packs from displaying brands and logos, despite accusations that the law violates international trademark law. According to Inside U.S. Trade, last week Beasley “dismissed U.S. companies’ claims that the plain packaging law… unjustifiably restricts the use of their trademarks in violation of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights.”

Philip Morris has also served a notice of claim on the Australian government, announcing its intention to challenge the law as a violation of the Australia’s investment treaty with Hong Kong.

Last month, the bill was the subject of debate at the TRIPS Council, where a group of developing countries suggested the legislation would violate Article 20 of TRIPS, which states: “The use of a trademark in the course of trade shall not be unjustifiably encumbered by special requirements.”